A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
Recruitment status was Active, not recruiting
The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation|
- Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient and graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]
- Quality of life (health survey) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of post-transplant diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ] [ Designated as safety issue: No ]
- Renal function [ Time Frame: one year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||December 2008|
subjects who remain on steroids after discharge
Subjects will be off steroids at the time of discharge
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.
With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.
Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.
|United States, Florida|
|Florida Hospital Transplant Center|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Michael Angelis, MD||Florida Hospital Transplant Center|